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Ischemic Stroke, AcutePhase 3TAPISNCT06316570

Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke

A Phase 3 study testing Early Dual Antiplatelet Therapy in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 60 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke, Acute
What is being tested?
Early Dual Antiplatelet Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,382 participants
Where
60 sitesChina
Study dates
3 Apr 2024to 5 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 18-80 years old;
  • 2. Clinical diagnosis of acute ischemic stroke;
  • 3. Time from onset to treatment ≤6.0 hours;
  • 4. Having received or planning to receive intravenous thrombolytic therapy;
  • 5. NIHSS score of 4-10 points, and at least one of the 5th (upper limb exercise) or 6 th (lower limb exercise) scale is ≥1 point;
  • 6. Signed informed consent.

Who cannot join

  • 1. Planning to receive endovascular therapy;
  • 2. mRS scores ≥2 points before the onset;
  • 3. Receiving any antiplatelet therapy after the onset;
  • 4. Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), identified by CT/MRI;
  • 5. Pre-existing clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
  • 6. Pre-existing atrial fibrillation or anticoagulant therapy (warfarin, heparin, thrombin inhibitors or factor Xa inhibitors);
Show all 11Show fewer
  • 7. Hepatic or renal insufficiency (hepatic insufficiency refers to the alanine transaminase (ALT) value > 2 times the upper limit of normal value or aspartate aminotransferase (AST) times > 2 times the upper limit of normal value; renal insufficiency refers to creatinine values > 2 times the upper limit of normal value);
  • 8. Allergic to Ticagrelor or Aspirin or thier components and excipients;
  • 9. Women who are pregnant or breastfeeding, or those with negative pregnancy test records while refusing to use effective contraceptives;
  • 10. Having participated investigational drugs or device tests within 30 days;
  • 11. Being considered inappropriate to participate by researchers.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

China60 sites

  • Anshan Changda Hospital

    Anshan, Liaoning

  • Puyang Anyang District Hospital

    Anyang, Henan

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The First Hospital of Fangshan District

    Beijing, Beijing Municipality

  • Benxi Central Hospital

    Benxi, Liaoning

  • Liuyang Jili Hospital

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chenzhou First People's Hospital

    Chenzhou, Hunan

  • Chenzhou Fourth People's Hospital

    Chenzhou, Hunan

  • Dalian Lvshun district people's hospital

    Dalian, Liaoning

  • Dalian University Affiliated Xinhua Hospital

    Dalian, Liaoning

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Dandong Central Hospital

    Dandong, Liaoning

  • Yantai Penglai Traditional Chinese Medicine Hospital

    Dengzhou, Shandong

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Lingbao First People's Hospital

    Henan, Sanmenxia

  • Heyuan City Hospital of Traditional Chinese Medicine

    Heyuan, Guangdong

  • Tuquan People's Hospital

    Hinggan, Inner Mongolia

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Neimenggu

  • Zhalantun City Hospital of Chinese and Mongolian Medicine

    Hulunbuir, Inner Mongolia

  • Henan Wenxian People's Hospital

    Jiaozuo, Henan

  • Jiaozuo People's Hospital

    Jiaozuo, Henan

  • Yuci District People's Hospital

    Jinzhong, Shanxi

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan

  • Kaifeng Central Hospital

    Kaifeng, Henan

  • Lankao County Hospital of Traditional Chinese Medicine

    Kaifeng, Henan

  • Qi County Traditional Chinese Medicine Hospital

    Kaifeng, Henan

  • Qixian People's Hospital

    Kaifeng, Henan

  • The People's Hospital of Weishi

    Kaifeng, Henan

  • Xiangfu District First People's Hospital

    Kaifeng, Henan

  • Linfen Central Hospital

    Linfen, Shanxi

  • Linfen People's Hospital

    Linfen, Shanxi

  • Linyi City People Hospital

    Linyi, Shandong

  • Luoyang First People's Hospital

    Luoyang, Henan

  • Luoyang Mengjin People's Hospital

    Luoyang, Henan

  • Song County People's Hospital

    Luoyang, Henan

  • Wuming Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Sanmenxia Hospital of the Yellow River, Affiliated to Henan University of Science and Technology

    Sanmenxia, Henan

  • Henan Sui County Hospital of Traditional Chinese Medicine

    Shangqiu, Henan

  • Suixian People's Hospital

    Shangqiu, Henan

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning

  • The First Afflicted Hospital of Shihezi University

    Shihezi, Xinjiang

  • Affiliated Hospital of North China University of Science and Technology

    Tangshan, Hebei

  • Tianjin Xiqing Hospital

    Tianjin, Tianjin Municipality

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong

  • Weinan Central Hospital

    Weinan, Shanxi

  • Weishi Central Hospital

    Weishi, Henan

  • Weishi County Central Hospital

    Weishi, Henan

  • Huangpi District People's Hospital of Wuhan City

    Wuhan, Hubei

  • Linxi County People's Hospital

    Xingtai, Hebei

  • Ningjin County Hospital of Hebei Province

    Xingtai, Hebei

  • Qinghe People's Hospital

    Xingtai, Hebei

  • Renze District People's Hospital

    Xingtai, Hebei

  • Xingtai Ninth Hospital

    Xingtai, Hebei

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Yulin First People's Hospital

    Yulin, Guangxi

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei

  • Yangyuan County People's Hospital

    Zhangjiakou, Hebei

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai, Guangdong

  • Zibo Municipal Hospital

    Zibo, Shandong

Other trials in China

About this study

Official title: Efficacy and Safety of Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis in Patients With Ischemic Stroke (TAPIS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial

Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke.

Read the detailed description

Theoretically, early administration of antiplatelet therapy is expected to counteract platelet aggregation during intravenous thrombolysis, improving the efficacy of intravenous thrombolysis as well as the functional prognosis. According to current evidence, mainstream guidelines clearly state that the administration of intravenous aspirin (or other antiplatelet agents) within 24 hours of Recombinant tissue plasminogen activator (rt-PA) thrombolytic therapy is not recommended as an adjunctive treatment of intravenous thrombolysis therapy, despite the fact that rt-PA thrombolytic therapy is still acceptable for patients who have received antiplatelet therapy before the onset of stroke. Evidence from high-quality clinical trials for the routine use of oral antiplatelet drugs before and within 24 hours of intravenous thrombolysis in acute ischemic stroke (AIS) patients is quite limited. Meanwhile, trials including INSPIRES and CHANCE 2 have demonstrated that early initiation of dual antiplatelet therapy could significantly reduce the risk of recurrence and thus improve the functional prognosis without significantly increasing the risk of bleeding, providing a promising treatment for early oral antiplatelet therapy in patients undergoing intravenous thrombolysis.

This trial is a multicenter, randomized, double-blind, placebo-parallel controlled designed clinical trial. A total of 1380 patients (aged 18-80 years) who have a new diagnosed ischemic stroke (within 6 hours of onset), a NIHSS score of 4-10 points, and have received/are planned to receive intravenous thrombolysis therapy with will be enrolled from 50 centers in China. Patients will be randomly assigned into intervention (dual antiplatelet therapy of Ticagrelor and Aspirin) and control group (placebo) by the ratio of 1:1. Face to face or distance (via video or telephone) interviews will be made at baseline, 7 ± 1 days, 30 ± 3 days, 60 ± 5 days and 90 ± 7 days after randomization.

Primary outcome is defined as good functional outcomes (mRS score of 0-1 points) at 90 days. Secondary outcomes include neurologic improvement，quality of life ( quality-of-life EuroQol-5 Dimensions scale)，activity of daily living (Barthel index)，recurrent ischemic stroke. Safety outcomes, relating to antiplatelet and intravenous thrombolysis therapy (i.e., symptomatic intracranial hemorrhage, parenchymal hematoma type 2, bleeding events) will also be investigated.

The Chi-square test was used to compare the proportion difference of good functional outcomes between two groups after 90 days of treatment, and the 95% confidence interval (CI) was calculated by using the Newcombe method. The generalized linear regression model was used to calculate the relative risk (RR) and its 95%CI. For survival outcomes, hazard ratio (HR) and 95% CI were calculated using the Cox proportional risk model.

Being tested
Early Dual Antiplatelet Therapy, Placebo
Keywords
Ischemic Stroke, Antiplatelet Therapy, Intravenous Thrombolysis, Randomized Controlled Trial, Double Blind Study, Multicenter Study, Clinical Trial
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Dual Antiplatelet TherapyDrug

    Also called Ticagrelor and Aspirin

    Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Ticagrelor (180mg) + Aspirin (100mg), one dose;

    Days 2-7: Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ;

    Days 8-90: open-label Aspirin (100mg/time, once/day).

  • PlaceboDrug

    Also called Placebo of Ticagrelor and Aspirin

    Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Placebo of Ticagrelor (180mg) + Placebo of Aspirin (100mg), one dose;

    Days 2-7: Placebo of Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ;

    Days 8-90: open-label Aspirin (100mg/time, once/day).

Study groups in NCT06316570
Study groupRoleWhat they receive
Dual Antiplatelet TherapyExperimentalThis group will receive early dual antiplatelet therapy (Ticagrelor with Aspirin) combined with intravenous thrombolysis within 6 hours of the onset.
Receives: Drug: Early Dual Antiplatelet Therapy
PlaceboPlacebo comparatorThis group will receive placebo treatment (with same form and dosage) combined with intravenous thrombolysis within 6 hours of the onset.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excellent functional outcome

    Modified Rankin Scale (mRS) score of 0-1 points; The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.

    Measured: 90 days

Secondary outcomes (13)

  1. mRS score of 0-2 points

    The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.

    Measured: 90 days

  2. Distribution of mRS score

    The distribution of mRS score of 0 to 6 points; The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.

    Measured: 90 days

  3. Neurologic improvement

    NIHSS score decreasing by 4 points or more than the value at baseline; The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.

    Measured: 7 days

  4. Quality of life (EQ-5D scale)

    The European Quality of Life 5-Dimension（EQ-5D）questionnaire for measuring generic health status. The 5-level EQ-5D version (EQ-5D-5L) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 25 (all domains have level 5), with higher scores indicating worse health-related quality of life.

    Measured: 90 days

  5. Activity of daily living (Barthel index ≥95 points)

    The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence.

    Measured: 90 days

  6. Recurrent ischemic stroke

    Measured: 90 days

  7. Symptomatic intracranial hemorrhage (ECASS-III)

    Measured: 36 hours

  8. Symptomatic intracranial hemorrhage (ECASS-III)

    Measured: 7 days

  9. Parenchymal hematoma type 2 (SIST-MOST)

    Measured: 36 hours

  10. Parenchymal hematoma type 2 (SIST-MOST)

    Measured: 7 days

  11. Bleeding events (GUSTO)

    Measured: 90 days

  12. Adverse events

    Measured: 90 days

  13. Severe adverse events

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start3 Apr 2024
  3. Primary completion31 Dec 2025
  4. Study completion5 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06316570
Sponsor's protocol ID
HX-A-2023044
Other IDs
SF 2024-2-2045
Acronym
TAPIS
Status last verified
Jan 2026
First submitted
12 Mar 2024
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zi X, He Y, Chen G, Wang Q, Xia X, Li J, Zhang X, Jing J, Bath PM, Turc G, Wang A, Wang Y; TAPIS Investigators. Ticagrelor-Aspirin With Thrombolysis by Infarct Patterns in Moderate Ischemic Stroke: TAPIS Subgroup Analysis. Stroke. 2026 Sep 3. doi: 10.1161/STROKEAHA.126.057001. Online ahead of print.

    PubMed 42689322

  • Wang A, Xia X, Tang Y, Zhang F, Han X, Li J, Zhang X, Wang J, Song Y, Che F, Bei Y, He Y, Jing W, Hao J, He J, Yang H, Chen S, Wu W, Li Y, Dai H, Yang C, Sun Z, Li L, Chen Y, Bath PM, Turc G, Wang Y; TAPIS Investigators. Ticagrelor with aspirin dual antiplatelet therapy combined with intravenous thrombolysis in patients with ischaemic stroke in China (TAPIS): a multicentre, double-blind, randomised controlled trial. Lancet. 2026 May 16;407(10542):1919-1928. doi: 10.1016/S0140-6736(26)00757-9. Epub 2026 May 8.

    PubMed 42114550

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Early Dual Antiplatelet Therapy in people with Ischemic Stroke, Acute, run by Beijing Tiantan Hospital at 60 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excellent functional outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06316570, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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